MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Date of implant: 2019.Exact date unknown.Initial reporter phone number: (b)(6).Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-17185.It was reported the patient lost effective therapy.Diagnostics indicated high impedances on the lead.During the lead revision surgery it was observed the lead and anchor were broken.In turn, the lead and anchor were explanted and replaced to address the issue.

Manufacturer Narrative

The reported event of broken/fracture swift lock anchor was confirmed.Visual inspection of the return swift-lock anchor revealed that the anchor was broken into 2 pieces.The cause of the fracture is consistent with an overstress condition or sudden event the anchor may have been subjected while in vivo.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12513752
• MDR Text Key: 272732845
• Report Number: 1627487-2021-17186
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2019
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5867836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD.; PERCUTANEOUS LEAD
• Patient Outcome(s): Other